Principal Scientist, Bioanalytical Lead
Company: Disability Solutions
Location: Princeton
Posted on: October 19, 2024
Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more:
.Position SummaryThe Bioanalytical (BA) function within CPPB is a
centralized function for testing biological samples for
Pharmacokinetics (PK), ADME biomarkers, and Immunogenicity
assessments. The responsibilities of the groups include providing
bioanalytical leadership on BMS drug development teams via
scientific/technical expertise and strategic input; overseeing
and/or performing assay development/ validation, and sample
analysis; supporting discovery studies for biotherapeutics and
regulated and non-regulated bioanalysis for toxicology and clinical
studies; and preparing appropriate documentation and/or interacting
with health authorities on the BA portion of regulatory filings.
The BA groups utilize both internal resources and external
strategic partners to ensure on-time delivery of BA data to enable
key decisions for the organization.The candidate for this position
has the responsibilities of providing bioanalytical leadership for
BMS development programs using LC-MS technology. The candidate for
this position works close with internal groups and CROs to provide
bioanalytical method development/validation/sample analysis
expertise, as well as regulatory interactions on BMS development
candidates. Key responsibilities
- Provide bioanalytical strategies related to BMS development
compounds from GLP studies to life cycle management.
- Provide leadership for bioanalytical issues for BMS development
candidates on project teams, oversees assay
development/validation/performance monitoring at CROs, ensures
on-time, high quality delivery of data and reports in support of
drug development.
- Provide leadership in authoring and reviewing of regulatory
filing documents (IND, NDA/BLA, IB, etc) and Interacts with Health
authority on BA related inquiries
- Represent regulated bioanalysis on cross functional teams and
contribute to the improvements to processes.
- Act as LC-MS Technology lead on cross-functional teams for
none-routine LC-MS BA analysis responsibilities such as protein
binding, AMS, LC-MS technology lead on biologics, biomarker,
etc.
- Enhance the scientific credibility of BMS through contributions
to the scientific literature (publications/presentations), through
extramural activities and scientifically related interactions with
academic and health authorities.
- May require travels to CROs for monitoring visits.Basic
Qualifications
- Bachelor's Degree
- 8+ years of academic and / or industry experienceOr
- Master's Degree
- 6+ years of academic and / or industry experienceOr
- Ph.D. or equivalent advanced degree in the Life Sciences
- 4+ years of academic and / or industry experiencePreferred
Qualifications
- A candidate with a PhD degree in related field is
preferred.
- A demonstrated background in regulated LC-MS bioanalysis
project management in a regulated organization (a CRO or a
pharmaceutical company) is required.
- The candidate must be well versed with sample preparation,
chromatographic separation, and mass spectrometric technology
utilized in regulated bioanalysis.
- The candidate should have a strong background in the principles
utilized in regulated bioanalysis, including a thorough
understanding of GxP regulations, and ICH M10.
- A demonstrated record of accomplishments in cross functional
leadership, scientific presentations, time management, and the
ability to work in a methodical and organized fashion.
- Ability to multi-task and work in a collaborative team
environment.
- Ability to communicate effectively in a team-based
environment.#LI - HybridIf you come across a role that intrigues
you but doesn't perfectly line up with your resume, we encourage
you to apply anyway. You could be one step away from work that will
transform your life and career. Uniquely Interesting Work,
Life-changing CareersWith a single vision as inspiring as
Transforming patients' lives through science--- , every BMS
employee plays an integral role in work that goes far beyond
ordinary. Each of us is empowered to apply our individual talents
and unique perspectives in an inclusive culture, promoting
diversity in clinical trials, while our shared values of passion,
innovation, urgency, accountability, inclusion and integrity bring
out the highest potential of each of our colleagues.On-site
Protocol BMS has a diverse occupancy structure that determines
where an employee is required to conduct their work. This structure
includes site-essential, site-by-design, field-based and
remote-by-design jobs. The occupancy type that you are assigned is
determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned
facility. Site-by-design roles may be eligible for a hybrid work
model with at least 50% onsite at your assigned facility. For these
roles, onsite presence is considered an essential job function and
is critical to collaboration, innovation, productivity, and a
positive Company culture. For field-based and remote-by-design
roles the ability to physically travel to visit customers, patients
or business partners and to attend meetings on behalf of BMS as
directed is an essential job function. BMS is dedicated to ensuring
that people with disabilities can excel through a transparent
recruitment process, reasonable workplace
accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to . Visit to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your area.If
you live in or expect to work from Los Angeles County if hired for
this position, please visit this page for important additional
information: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, Fairfield , Principal Scientist, Bioanalytical Lead, Other , Princeton, Connecticut
Didn't find what you're looking for? Search again!
Loading more jobs...